BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 905853 · Received August 30, 2007

    Report

    Report Number
    1823260-2007-07681
    Event Type
    Malfunction
    Date Received
    August 30, 2007
    Date of Event
    August 22, 2007
    Report Date
    August 30, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED DISCREPANT BACK TO BACK BLOOD GLUCOSE VALUES OF 150, 327, 176, AND 25 MG/DL WHEN ALL TESTS WERE PERFORMED ONE MINUTE APART ON THE ADVANTAGE SYSTEM. REPORTER STATED THE CUSTOMER WAS TREATED BY THE PARAMEDICS WITH A GLUCOSE IV BECAUSE 911 WAS CALLED WHEN THE CUSTOMER WAS FOUND ON THE FLOOR, HOWEVER, THE VALUE THE TREATMENT WAS BASED UPON WAS NOT KNOWN. IT WAS STATED THE ADVANTAGE SYSTEM READ 125 MG/DL HIGHER THAN THE PARAMEDIC METER, HOWEVER, IT WAS NOT KNOWN WHEN THE SYSTEM READING WAS TAKEN IN COMPARISON TO THE PARAMEDIC VALUE. NO OTHER ACTIONS WERE TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 549845

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR NOVOLIN R - UNK DOSAGE & DURATION| LISINOPRIL - 5MCG ONCE DAILY